Knee Osteoarthritis Clinical Trial Design: An Imaging-Based Approach

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Drug Discovery & Development, Medical Device, Medical Device Clinical Trials,
  • Friday, November 05, 2021

Osteoarthritis of the knee is a leading cause of disability in the world, especially among the elderly population. In the United States, multiple common risk factors, such as increasing average age and obesity, have led to a rise in knee osteoarthritis incidence. As such, novel therapies and treatments that can slow down, halt, or even reverse the progression of disease are in high demand, and biotech and pharmaceutical companies are continuing to design clinical trials that test the safety and efficacy of new products.

Imaging plays an important role in the design of such clinical trials, as selecting the appropriate imaging modalities, assessments, and endpoints are critical to conducting a successful study. Imaging can be leveraged as part of the subject selection process to identify osteoarthritis phenotypes and to stratify patient populations that are appropriate for a trial. Depending on the type of treatment, imaging assessments can also be designed to focus on the structural correlates of pain, or to evaluate structural changes in cartilage and bone for disease modification claims.

In the first half of this webinar, Dr. Timothy Mosher will provide attendees with a basic understanding of the common imaging modalities for evaluation of knee osteoarthritis and how imaging can be used for subject selection and evaluation of the investigational product for two types of knee osteoarthritis clinical trials: treatments focused on symptom modification and treatments focused on cartilage repair.

In the second half of the webinar, Dave McGurl and Iman Ahmad will discuss endpoint design and other regulatory considerations for those two scenarios, as well as the importance of properly monitoring sites for imaging protocol compliance and image quality throughout osteoarthritis clinical trials.

Register for this webinar to learn how imaging can be leveraged for knee osteoarthritis clinical trials focused on symptom vs. structural modification, and the practicality and implementation of common X-ray vs. MRI assessments.

Speakers

http://Timothy%20J.%20Mosher,%20Medical%20Metrics

Timothy J. Mosher, MD., Kenneth L. Miller Chair, Department of Radiology at Penn State University; Radiologist Consultant and Faculty Director at Medical Metrics, Inc.

Dr. Mosher is the Kenneth L. Miller Chair, Department of Radiology at Penn State University and Distinguished Professor of Radiology and Orthopaedic Surgery. He is a clinical musculoskeletal radiologist researching quantitative MRI for evaluation of articular cartilage and osteoarthritis and application of MRI in multicenter clinical trials.

Dr. Mosher is active in the field of diagnostic error in medicine, serving as a member of the Board of Directors for the Society to Improve Diagnosis in Medicine (SIDM) and representative of Penn State Health in the Coalition to Improve Diagnosis. He is also a fellow of the International Society for Magnetic Resonance in Medicine (ISMRM).  Previously, Dr. Mosher served as Deputy Editor for Magnetic Resonance in Medicine and Associate Editor for Osteoarthritis and Cartilage. He currently serves as an Associate Editor for MRI for the journal Radiology.

He is a member of the SBSR/NIH study section and served on the Scientific Advisory Board for the Canadian Arthritis Network and the Canadian Foundation for Innovation. Dr. Mosher has published 70+ books and manuscripts, with the majority in the area of musculoskeletal imaging, quantitative cartilage imaging, and MRI technical development. He also serves as an expert consultant and faculty director for Medical Metrics, Inc. (MMI).

Message Presenter
http://Iman%20Ahmad,%20MCRA

Iman Ahmad, Senior Director, Clinical Affairs, MCRA, LLC

Ms. Ahmad is a clinical expert with 16+ years’ experience in managing pharmaceutical and device studies, including domestic US trials, and larger multinational global studies. She works closely with the Regulatory department in the development and submission of IDE, IND, 510(k), and PMA applications for IVD, wound care and orthopedic devices.

As Sr. Clinical Director, Iman leverages her knowledge of FDA regulations and ICH/GCP guidelines to design pre- and post-market clinical studies in a manner that helps drive clinical and regulatory compliance and ensures superior data quality. She has assisted with the development of clinical protocols that incorporate strategic regulatory, statistical and reimbursement objectives so that our clients can use each clinical trial to collect data required by all stakeholders. She also advises clients on the use of innovative statistical analyses that can help reduce a study’s sample size and/or allow for an early success/failure determination. She assists clients with the identification and qualification of sites that help ensure their trial’s success. Iman also provides strategic guidance to clients on how to maintain inspection readiness at research sites, and how to prepare for a BIMO inspection.

Message Presenter
http://Dave%20McGurl,%20MCRA,%20LLC

Dave McGurl, Senior Director, Regulatory Affairs, MCRA, LLC

Mr. McGurl worked for 7 years at the FDA in the premarket orthopedic devices branch prior to joining MCRA in 2016. During his time at FDA, Mr. McGurl held several positions, including acting branch chief of the orthopedics branch and senior premarket lead reviewer. Throughout his professional career, Mr. McGurl has reviewed or written hundreds of regulatory submissions, including 510(k)s, PMAs, De Novos, IDEs, HDEs, CERs, STEDs, Technical Files, and Design Dossiers.

Mr. McGurl is a seasoned regulatory expert with proficiency in US and international medical device regulations. Mr. McGurl specializes in regulatory strategy, writing of regulatory submissions, clinical protocol design and development, analysis of preclinical and clinical data, and regulatory compliance review of marketing/labeling materials for medical devices. Mr. McGurl’s work at MCRA focuses primarily on both international and US medical devices with a specialization in orthopedic arthroplasty, trauma, and sports medicine.

Message Presenter

Who Should Attend?

This webinar will benefit those working in the following areas:

  • Medical monitors, clinical scientists and trial managers designing and running osteoarthritis clinical trials
  • Biostatisticians responsible for analysis of osteoarthritis imaging data
  • Academic researchers and scientists in the osteoarthritis field

What You Will Learn

In this webinar, attendees will learn about:

  • Practicality and implementation of common X-ray vs. MRI assessments in knee osteoarthritis clinical trials
  • How imaging can be leveraged for trials focused on symptom vs. structural modification
  • Regulatory considerations when designing imaging endpoints
  • Tips for monitoring site compliance and image quality

Xtalks Partners

Medical Metrics

Medical Metrics Inc. (MMI) is an experienced provider of medical imaging core laboratory services for multicenter clinical trials. MMI’s ISO 9001-certified services include imaging protocol development, medical image management, independent image review, and scientific consulting. With 20+ years of experience on hundreds of studies, MMI can support global trials ranging from early-phase feasibility to post-market surveillance across a range of therapeutic areas, including orthopedics, spine, neurology, cardiology, vascular and surgical interventions, ENT, and AI/ML technologies.

MCRA

MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices.

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